Salix to Present Data from XIFAXAN(R) (Rifaximin) Clinical Research at EASL's International Liver Congress(TM) 2023

Three XIFAXAN® (rifaximin) Research Posters to Be Featured

LAVAL, QC / ACCESSWIRE / June 19, 2023 / Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) and its gastroenterology business, Salix Pharmaceuticals, today announced its presence at the European Association for the Study of the Liver (EASL) Congress 2023. XIFAXAN® (rifaximin) data was selected for inclusion in the Cirrhosis and its complication's session. EASL Congress 2023 will be held virtually and in-person in Vienna, Austria, from June 21-24, 2023.

The Salix research to be featured at EASL Congress 2023 and available in person and via the meeting's online platform is as follows:

XIFAXAN

• Bajaj, Jasmohan S. et al. "Rifaximin plus lactulose is more effective than lactulose alone for the prevention of overt hepatic encephalopathy in patients with or without diabetes"
  • Wednesday, 21 Jun, 09:00 - 09:00 CEST
• Bajaj, Jasmohan S. et al. "Serum ammonia levels do not correlate with overt hepatic encephalopathy severity and time to resolution in hospitalized patients with cirrhosis"
• Wednesday, 21 Jun, 09:00 - 09:00 CEST
• Heimanson, Zeev. et al. "Impact of rifaximin use post-discharge of an overt hepatic encephalopathy (OHE) hospitalization on the annual rates of OHE-related inpatient stays"
• Saturday, 24 Jun, 09:00 - 09:00 CEST

About XIFAXAN

XIFAXAN^® (rifaximin) 550 mg tablets are indicated for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults and for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.

IMPORTANT SAFETY INFORMATION

• XIFAXAN is contraindicated in patients with a hypersensitivity to rifaximin, rifamycin antimicrobial agents, or any of the components in XIFAXAN. Hypersensitivity reactions have included exfoliative dermatitis, angioneurotic edema, and anaphylaxis.
• Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including XIFAXAN, and may range in severity from mild diarrhea to fatal colitis. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.
• There is an increased systemic exposure in patients with severe (Child-Pugh Class C) hepatic impairment. Caution should be exercised when administering XIFAXAN to these patients.
• Caution should be exercised when concomitant use of XIFAXAN and P-glycoprotein (P-gp) and/or OATPs inhibitors is needed. Concomitant administration of cyclosporine, an inhibitor of P-gp and OATPs, significantly increased the systemic exposure of rifaximin. In patients with hepatic impairment, a potential additive effect of reduced metabolism and concomitant P-gp inhibitors may further increase systemic exposure to rifaximin.
• In clinical studies, the most common adverse reactions for XIFAXAN were:
  • -HE (≥10%): Peripheral edema (15%), nausea (14%), dizziness (13%), fatigue (12%), and ascites (11%)
  • -IBS-D (≥2%): Nausea (3%), ALT increased (2%)
• INR changes have been reported in patients receiving rifaximin and warfarin concomitantly. Monitor INR and prothrombin time. Dose adjustment of warfarin may be required.
• XIFAXAN may cause fetal harm. Advise pregnant women of the potential risk to a fetus.

To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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